It’s possible Dr. Prasad will tire of his family and return to the FDA
The TV show known as our Medical Establishment has a new plot twist, one I suspected may be coming. In what I desperately hoped would be my last article on Dr. Vinay Prasad, I wrote “it’s possible Dr. Prasad will tire of his family and return to the FDA“. I wrote that not just because RFK Jr. and Dr. Marty Makary didn’t want Dr. Prasad to leave in the first place, but because the official story was that he resigned voluntarily. HHS spokesperson Andrew Nixon said at the time:
Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family. We thank him for his service and the many important reforms he was able to achieve in his time at FDA.
Predictably, Dr. Makary was eager to promote the narrative that Dr. Prasad left entirely of his own accord to be with his loved ones. He said it on camera multiple times. Anything less would be an admission that staffing decisions at the FDA were made for political reasons by a mercurial President under the influence of nefarious actors. As such, he said:
He’s 42 years old, he gave us some of his time. He’s got family in California. The commute was brutal. And then when he saw some of these sort of smear pieces, he didn’t want to be a distraction.
Dr. Makary also said that idea that Dr. Prasad “was pushed out by anybody is simply untrue.”
FDA official returns to agency after Loomer-led ouster
Well, that plot twist arrived, and Dr. Prasad is back. As I wrote previously, his departure was not necessarily a good thing, and his return is not necessarily a bad thing. Despite his litany of misinformation, juvenile conduct, and reported disinterest in his job at the FDA, there are many worse choices than Dr. Prasad, amazingly.
However, important questions remain. Did Dr. Prasad really tire of his family that quickly? Did he change his mind about the commute? Is he no longer worried about being a distraction? Did Dr. Prasad actually have multiple, dramatic changes of heart about his entire career in the span of one week?
No one believes this, of course. Multiple news outlets reported that Trump demanded Dr. Prasad’s resignation and that he was influenced by a combination of Laura Loomer, Big Pharma, the WSJ, patient advocates, the right-to-try folks. All of Dr. Prasad’s defenders embraced this narrative. None of them believed Dr. Makary, and they announced their disagreement with him in public for the first time. Dr. Makary’s anti-vaccine disinformation, fake statistics, and false declarations of herd immunity didn’t bother them a bit, but spinning a fairy tale about Dr. Prasad’s departure from the FDA was a bridge too far. That demanded vigorous pushback!
I will be ramping up my exposes of officials with HHS and FDA
Of course, the return of Dr. Prasad doesn’t mean that things are fine and dandy at the FDA. Trust and moral at there are at an all-time low. Important staffing decisions seem to be made on a whim. As John Carol said:
And just like that, Vinay Prasad is back at the helm of CBER. From the convos I’ve been having, it’s safe to say that no one in biotech understands which end is up at the FDA. The agency included a swipe at “the fake news” in making the announcement. But a simple chronology of events underscores the turmoil at the agency. One exec I talked with in recent weeks likened clinical research these days to traveling a dirt road, with a drunk, gun waving sheriff in charge. Can you imagine what it’s like working at the FDA now? Amateurs and antagonists. Absurd.
Meanwhile RFK Jr. is devastating vaccines, as we knew he would, the FDA’s AI is hallucinating, deluded anti-vaxxers are shooting up the CDC, and CBER staff are likely not overjoyed that “boy wonder” is back. According to one news report:
FDA workers reacted to the decision to bring back Prasad with incredulousness, according to one FDA staffer who said several coworkers were alternating between being sad and concerned. Roughly a quarter of the 3,500 agency employees who originally were given reduction-in-force notices earlier this year have been reinstated, but staff morale remains low even as Makary tries to fill a higher-than-average job vacancy rate among scientific reviewers.
No one, not even Dr. Prasad’s greatest supporters, can make the affirmative case that things are going well right now.
It’s Drs. Prasad’s and Makary’s job to fix this, and they have a lot of work to do. They chose this. At a bare minimum, they owe us a full and honest accounting of Dr. Prasad’s resignation and return. This isn’t just about drama and palace intrigue. Dr. Prasad isn’t returning to the same FDA he left, and it’s inconceivable that his recent experiences won’t impact his future decisions. Laura Loomer, Big Pharma, the WSJ, patient advocates, and the right-to-try folks are still out there after all. We’ve all seen what they can do when they are angered. Most importantly, Trump is still their boss.
Link to original
Moving forward, how will Drs. Prasad and Makary navigate these treacherous waters? Did they make assurances to the higher-ups in the Oval Office that they would be less stringent in their drug approvals? Can we be assured that they will make their decisions based on science and evidence alone? Will they be constantly looking over their shoulder? Can they keep this up for 3.5 more years? Can Trump resist calls for their ouster for that long? How secure are their jobs?
To restore trust, Drs. Prasad and Makary need to venture out of their safe space and answer these basic questions from a tough but fair journalist. People universally view Dr Makary as an unreliable reporter about major staffing decisions at the FDA. I don’t know anyone, not one person, who believes his version of events, and it’s a problem that no one trusts our FDA leadership. Maintaining the fiction that Dr. Prasad resigned and returned entirely on his own, as I expect they will do, won’t fool anyone. Dr. Prasad said that “distrust in public health is good” and now people don’t trust public health. Not only does Dr. Prasad’s mission to restore trust remains unfulfilled, his main accomplishment during his first 3 months in office was to make everyone distrustful of the FDA.
Of course, everything Drs. Prasad and Makary say must be taken with a wheelbarrow of salt. They have both been utterly untrustworthy for the past 5 years, falsely numbing people to grave risks of both COVID and RFK Jr. It’s vital to remember their track record and past reliability when they discuss how wonderful things are at the FDA today.
Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration.
If I had any influence, Drs. Prasad and Makary would never have their current jobs. Yet, if I could push a magic button and have them succeed at the FDA, I would do so without hesitation. We all need safe food and medications. While I will hold them accountable, I am not rooting for the FDA to crumble under their watch. If 3.5 years from now the FDA is widely trusted and viewed as competent, I will gladly write about it here at SBM.
However, I am not confident this will happen. Things don’t usually end well for employees of Donald Trump, and I don’t think 3.5 years from now I will be writing about how Drs. Prasad and Makary overcame their doubters and turned the FDA into a well-oiled machine. Their first months in office have revealed their utter ineptitude- Inside the Collapse of the F.D.A.– and so far, instead of leveling with the public about Dr. Prasad’s resignation and return, we’ve only gotten rank gaslighting. According to that same HHS spokesperson Andrew Nixon, Dr. Prasad’s brief absence was imagined by “fake news media.” He said:
At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research. Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration.
It will be impossible to trust anything at the FDA going forward when important and serious questions about its leaders generate tantrums and fabrications from HHS spokespeople. Dr. Prasad does not have to reveal any personal gossip about why he tired of his family so soon, of course, but the American public deserves to the full story about his temporary resignation and how this might impact his regulatory decisions moving forward. This is not an outrageous ask. It’s just asking for honesty and transparency from our medical establishment. That’s all.
There’s a first time for everything.
